Knotty-Tide Consulting

Providing Simple and Effective Solutions that Improve Animal Health.

One Submission at a Time.

Who We Are & What We Do

Knotty-Tide is a specialized pharmaceutical consulting firm. We focus on U.S. regulation applied to the Chemistry, Manufacturing, and Controls (CMC) Technical Section of prescription animal drug applications. Our services are dedicated to the animal health industry and FDA’s Center for Veterinary Medicine (CVM) regulations.

Knotty-Tide asks your team the right questions at the right time, identifying regulatory gaps, and applying scientific justification throughout your CMC submissions. Our goal is to minimize FDA review cycles. Our value is measured by enhanced submission quality and risk mitigation. By working together, we expedite your return on investment and improve animal health.

 

CMC Services

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Knotty-Tide Consulting is a U.S. based Regulatory Affairs consulting company. Globally, we work with pharmaceutical companies, contract manufacturing organizations (CMOs), and a network of Subject Matter Experts (SMEs) to bring animal brand (NADA/INAD) and generic (ANADA/JINAD) prescription medications to the U.S. market. Knotty-Tide’s CMC Core Competencies Include:

  • Write, Publish, and/or Review

  • Electronic Submissions

  • CMC Strategy

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Write, Publish, and/or Review

  • Formal & Informal CMC Correspondence with CVM

  • Question based Review (QbR) (eCTD Module 2)

  • CMC Technical Section (eCTD Module 3)

  • CMC Protocol & Report Review

  • Pre-Approval CMC Submission (INAD/JINAD, Reactivations, Amendments)

  • Post-Approval CMC Submission (CBEs, PAS, MCSR)

  • Deficiency Letter Response

  • Organize and Compile Final Submissions (Publishing: Build PDF/Bookmark PDF/Hyperlink PDF)

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Electronic Submissions

  • Advise/Train on eSubmitter Basics

  • eSubmitter Service (author, review, publish, and package electronic CMC submissions)

  • Electronically File (Knotty-Tide Consulting maintains a Web Trader (ESG) Account)

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CMC Strategy

  • Chemistry, Manufacturing, and Controls (CMC) Regulatory Consulting (pre/post approval)

  • Drug Development Regulatory Consulting

  • Interpretation of FDA-CVM Regulation & Requirements

  • Submission Gap Analysis & Risk Mitigation

  • Communicate and Explain CVM’s CMC Expectations

  • Pre- and Post-Approval Submission Planning (Document Requirements & Timelines)

  • Regulatory Strategy for Product Development

  • Regulatory Strategy for Technical Transfers

  • FDA Correspondence Strategy

  • Lifecycle Management (Impact Assessment for Proposed CMC Changes)

 

Contact Knotty-Tide

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Every job is unique. Whether you have a simple one-hour project or a more complicated issue that requires a longer commitment, we can help. Call, email, or complete the form below to discuss.

Phone: 717-891-7145
Email: jennifer.rice@knottytide.com

 

About Knotty-Tide Consulting

Strategic Regulatory Solutions

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Knotty-Tide Consulting was founded on the coastline of Portland, Maine. Much like the imagery of knotted ropes and shifting tides, navigating regulation is interpretive, technically complicated, and requires thoughtful planning. Knotty-Tide simplifies this intricate process by assisting regulatory and development teams with their Chemistry, Manufacturing, and Controls (CMC) Technical Section. Our expertise can be applied to multiple dosage forms and throughout regulatory challenges. Due to our life-long love for animals, we specifically serve the animal health pharmaceutical industry.

Knotty-Tide focuses predominantly on pre- and post-approval CMC submissions to FDA's Center for Veterinary Medicine (CVM). Our core competency is writing, reviewing, and building processes around the creation and submission of CMC documentation. In the early stages of product development, we provide comprehensive strategies to address FDA regulation and CVM-specific expectations. We work hand-in-hand with your team to explain U.S. requirements, identify regulatory risks, and consult with CVM’s review teams to expedite approval. Together, we build a CMC dossier that showcases your company’s efforts to navigate FDA regulation successfully.

With over a decade of CVM-CMC experience, Knotty-Tide's regulatory team works globally with pharmaceutical companies to help deliver safe and efficacious medications to the United States companion and production animal industry.

 

Meet the Team

The drug approval process is complex, as is a team’s strategy and resilience needed to be successful. To best serve our clients, Knotty-Tide partners with various independent experts who deliver experience and expertise beyond the CMC Technical Section. A few of our experts are showcased below.

We look forward to working with you!

 

Jen Rice

Jen Rice Total Badass

Jen Rice grew up on a small farm in Dover, Pennsylvania. During that time, her experience taking care of animals grew into a passion for their health and wellbeing. Jen focused that interest at Virginia Tech, where she received a bachelor’s degree in Animal and Poultry Sciences, with an Emphasis in Equine Reproduction. Upon graduating, she pursued a career in animal health pharmaceuticals. For more than ten years, Jen worked in regulatory affairs, predominantly on pre- and post-approval CMC submissions of brand and generic animal drugs. During that time, she earned a master’s degree from Temple University in Quality Assurance and Regulatory Affairs.

In 2017, she founded Knotty-Tide Consulting, a specialty firm focused on FDA’s Center for Veterinary Medicine (CVM) CMC regulations. She started Knotty-Tide because she saw an opportunity to focus her professional purpose, “Improve animal health, one submission at a time.”

Jen is a member of the Parenteral Drug Association (PDA), Generic Animal Drug Alliance (GADA), and a sponsored member of the Animal Health Institute (AHI). She has been the regulatory lead and support on multiple first-to-market generic products, currently consults for 4 of the top 10 largest animal health pharmaceutical companies globally, and has held numerous leadership positions within her membership organizations. With a dog in tow (Turkish), Jen works and lives in Portland, Maine.

 

Jodi Beaudry

Jodi Beaudry

Jodi Beaudry, MS, is President of Beaudry Consulting, LLC. Jodi pursued a career in veterinary medicine as a Veterinary Technician from 1996–2007. In that time, she earned her Bachelor of Science degree in Molecular Biology at the University of Wyoming and then a Master of Science degree in Biology with a focus in biological statistics and assay validation at Northern Arizona University. In 2010 she took a position in the Animal Health pharmaceutical industry. There she advanced in numerous regulatory affairs roles for animal drug approvals that span companion and production animal drugs of many dosage forms in the generic and brand product space.

Jodi has also been privileged to serve as an Officer for the Generic Animal Drug Alliance (GADA) for 2 terms. As a GADA member, Society for Quality Assurance (SQA), and working groups with AHI and the Center for Veterinary Medicine, she continues to pursue pathways for quality animal drug products. Jodi lives and works from her home office in Centerville, Utah.

Jodi’s Specialties: CMC consulting; GLP and Non-GLP Consulting; FOI; Suitability Petitions; Label Content Development; Submission review.

 

Deborah Eyer Garvin

Deborah Eyer Garvin

Deborah Eyer Garvin, MS, RQAP-GLP is President of Pacific Rim GLP Consulting and Training. Ms. Garvin has been involved in Regulatory Research since 1986 and was President of Pacific Rim Consulting and West Coast Quality Training Institute from 1992-2015, providing training and consulting in FDA, EPA and OECD GLPs and FDA CVM GCPs.

In January 2015, Debi closed her 20 plus year consulting business to take a job with CVM FDA establishing Quality Assurance Study Review policies and processes, now known as the QASR group. In June 2017 she went back into the industry where she served as the GLP/GCP Manager for Huvepharma, Inc. Since May 2020, Deb reopened her consulting and training business and is currently an independent contractor located in Dexter, Oregon.

Deb’s Specialties: FDA/EPA/OECD GLPs consulting; Veterinary GCPs; Submission review; Facility Inspections; Study and Data audits, training in GLPs.

 

Turkish

Turkish

In the summer of 2012, Turkish found Jen in Nyack, New York. He is a man of unknown origin and variety. He is incredibly handsome, intelligent, and rugged. He enjoys a tennis ball and has a good sense of humor. Nine years young, he’s all heart & soul.